Biosimilar monoclonal antibodies: Challenges and approaches towards formulation.

Many biologic drug products, particularly monoclonal antibodies (mAbs), were off-patented between 2015 and 2020, and this process is continuing as the number of biologics approvals has increased. However, the availability of affordable biosimilars is delayed by secondary patents related to the formulation and manufacturing process. Therefore, an alternative formulation development is required to avoid infringement of formulation related patents.